510(k) · Cleared
Recalled · Class II · 2023WATCHDOG Hemostasis Valve Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corporation · DQX Wire, Guide, Catheter
Cleared on Nov 9, 2017 as substantially equivalent to K122301 (Vascular Solutions Zerusa, Ltd., 2012) and 1 other predicate after an 87-day review. Its family tree reaches back 7 generations to 1985. 2 of the 13 devices in its family, counting itself, have a Class I recall. It has been recalled 2 times.
- Decided
- Nov 9, 2017
- Review
- 87 days
- Class
- Class II
- Product code
- DQX
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 7 generations to K854261 (1985). 12 ancestors in all. No later device cites it as a predicate yet. 2 of the 13 devices in this family, counting this one, have a Class I recall.
- Root · 7 generations backK854261 Advanced Cardiovascular Systems Hemostatic ValvesAdvanced Cardiovascular Systems, Inc. · 1985 · Recalled
- 6 generations backK991102 Copilot Bleedback Control Valve, Model 1003331Guidant Corp. · 1999 · Recalled
- 5 generations backK042060 Easypass US Y-Connector Hemostatic ValveMillimed A/S · 2004
- 4 generations backK052381 Guardian Hemostasis Valve with Guidewire IntroducerZerusa Limited · 2005
- 3 generations backK073620 Guardian Hemostasis ValveZerusa Limited · 2008
- 2 generations backK092711 Guardian II Hemostasis ValveZerusa Limited · 2009 · Recalled (Class I)
- 1 generation backK122301 Guardian II Hemostasis Valve Guardian II NC Hemostasis ValveVascular Solutions Zerusa, Ltd. · 2012 · Recalled (Class I)
- This deviceK172453 WATCHDOG Hemostasis Valve KitBoston Scientific Corporation · 2017
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K854261 | Advanced Cardiovascular Systems Hemostatic Valves | Advanced Cardiovascular Systems, Inc. | 1985 | 2 |
| −6 | K991102 | Copilot Bleedback Control Valve, Model 1003331 | Guidant Corp. | 1999 | 1 |
| −5 | K042060 | Easypass US Y-Connector Hemostatic Valve | Millimed A/S | 2004 | — |
| −4 | K052381 | Guardian Hemostasis Valve with Guidewire Introducer | Zerusa Limited | 2005 | — |
| −3 | K073620 | Guardian Hemostasis Valve | Zerusa Limited | 2008 | — |
| −2 | K092711 | Guardian II Hemostasis Valve | Zerusa Limited | 2009 | Class I |
| −1 | K122301 | Guardian II Hemostasis Valve Guardian II NC Hemostasis Valve | Vascular Solutions Zerusa, Ltd. | 2012 | Class I |
| 0 (this device) | K172453 | WATCHDOG Hemostasis Valve Kit | Boston Scientific Corporation | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
2 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DQX device
- #1 K213854 SavvyWirescore 15.7 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K122301 | Guardian II Hemostasis Valve Guardian II NC Hemostasis ValveSummary page 5…ERN: 3002807314 WATCHDOG™ Hemostasis Valve Kit: Predicate Device(s) ® Guardian II Hemostasis Valve K122301 (cleared September 7, 2012) Insertion Tool: Insertion Tool K140673 (cleare… | 2012 |
| * | K140673 | Insertion ToolSummary page 5…Guardian II Hemostasis Valve K122301 (cleared September 7, 2012) Insertion Tool: Insertion Tool K140673 (cleared April 16, 2014) Reference Device(s) WATCHDOG™ Hemostasis Valve Kit: GateWay™ PLUS Y-A… | 2014 |
| † | K951089 | Scimed Gateway Plus | 1995 |
| † | K991102 | Copilot Bleedback Control Valve, Model 1003331 | 1999 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 5, 2023 | Class II | Z-1592-2023 | Process control | The firm received complaints of the Insertion Tool component being occluded, resulting in the inability to pass a guidewire through the tool. |
| Apr 5, 2023 | Class II | Z-1593-2023 | Process control | The firm received complaints of the Insertion Tool component being occluded, resulting in the inability to pass a guidewire through the tool. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K122301Guardian II Hemostasis Valve Guardian II NC Hemostasis ValveVascular Solutions Zerusa, Ltd. · 2012 · Direct predicate · ◆ on the line of descent in FIG. 12 Class I recalls
- K092711Guardian II Hemostasis ValveZerusa Limited · 2009 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 32 years and passes through 6 companies; a new generation was cleared every 2.9 years on median.
- 4 of the 12 ancestors have a recall of any class; 2 have a Class I recall.
How does its category compare?
All DQX devicesDQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · DQX
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQX
177in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQX
3in 2024
Class I (8 since 2007) Class II/III not classified
Adverse event reports per year · DQX
2,178in 2025
MAUDE reports naming product code DQX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 14 | 85 | 12 | 760 |
| 2008 | 19 | 87 | 7 | 715 |
| 2009 | 18 | 87 | 49 | 687 |
| 2010 | 21 | 63 | 34 | 987 |
| 2011 | 18 | 43 | 3 | 1,311 |
| 2012 | 20 | 62 | 5 | 1,337 |
| 2013 | 18 | 119 | 7 (4) | 1,474 |
| 2014 | 18 | 103 | 0 | 1,323 |
| 2015 | 15 | 112 | 1 | 1,323 |
| 2016 | 14 | 179 | 2 (2) | 1,466 |
| 2017 | 19 | 85 | 17 | 1,524 |
| 2018 | 19 | 114 | 9 | 1,737 |
| 2019 | 13 | 173 | 2 | 1,679 |
| 2020 | 14 | 106 | 1 (1) | 1,536 |
| 2021 | 6 | 161 | 0 | 1,713 |
| 2022 | 15 | 212 | 0 | 1,647 |
| 2023 | 10 | 136 | 0 | 2,068 |
| 2024 | 11 | 134 | 3 | 2,210 |
| 2025 | 10 | 177 | 0 | 2,178 |
| 2026 | 12 | 145 | 4 (1) | — |
What is it indicated for?
The WATCHDOG™ Hemostasis Valve is intended to maintain hemostasis during diagnostic/ interventional procedures.
The WATCHDOG™ Hemostasis Valve is indicated for maintaining a seal around diagnostic/ interventional devices with combined outer diameters of up to 8F [0.105 in (2.67 mm)] during diagnostic/ interventional procedures.
The Insertion Tool is used to facilitate the introduction of a guidewire during general intravascular procedures.
The Torque Device is used for guidewire manipulation during general intravascular procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172453 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172453: WATCHDOG Hemostasis Valve Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172453
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026